BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 15801379 · Received November 15, 2022

    Report

    Report Number
    3013756811-2022-127909
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 25, 2022
    Report Date
    January 18, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RESUME PUMP ALARM WAS RECEIVED WHEN INSULIN DELIVERIES HAD NOT BEEN STOPPED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 231-300 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774512 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male INFUSION: TRUSTEEL